Compliance with FDA’s eCTD requirements need not be a burden for any size company when “renting” a solution is just as effective as making the investment to buy a solution.
The datasets can be presented as Tabulation Datasets (CDISC SDTM format), Listings Datasets and Analysis Datasets. Please refer to FDA Study Data specifications (http://www.fda.gov/cder/regulatory/ersr/Studydata.pdf) for the format and folder structure of datasets and associated documentation.
The documentation for the datasets should be included in a data definitions file (define.pdf or define.xml) and annotated case report form (blankcrf.pdf). Additional information about the SAS transport file format can be found at http://www.sas.com/fda-esub. Specifications for SDTM and data definitions file can be found on the CDISC website: http://www.cdisc.org/models/sdtm/v1.1/index.html. Datafarm offers software and services to sponsors to assist them in the creation of SAS transport files and define files for the submission.
If you have any questions or would like more information, please see our website (www.datafarminc.com) or email us at firstname.lastname@example.org.